Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA -- CONTENTS -- LIST OF ILLUSTRATIONS -- LIST OF TABLES -- ACKNOWLEDGMENTS -- LIST OF ABBREVIATIONS AND ACRONYMS -- INTRODUCTION The Gatekeeper -- CHAPTER ONE Reputation and Regulatory Power -- PART ONE: ORGANIZATIONAL EMPOWERMENT AND CHALLENGE -- CHAPTER TWO Reputation and Gatekeeping Authority: The Federal Food, Drug and Cosmetic Act of 1938 and Its Aftermath -- CHAPTER THREE The Ambiguous Emergence of American Pharmaceutical Regulation, 1944-1961 -- CHAPTER FOUR Reputation and Power Crystallized: Thalidomide, Frances Kelsey, and Phased Experiment, 1961-1966 -- CHAPTER FIVE Reputation and Power Institutionalized: Scientific Networks, Congressional Hearings, and Judicial Affirmation, 1963-1986 -- CHAPTER SIX Reputation and Power Contested: Emboldened Audiences in Cancer and AIDS, 1977-1992 -- PART TWO: PHARMACEUTICAL REGULATION AND ITS AUDIENCES -- CHAPTER SEVEN Reputation and the Organizational Politics of New Drug Review -- CHAPTER EIGHT The Governance of Research and Development: Gatekeeping Power, Conceptual Guidance, and Regulation by Satellite -- CHAPTER NINE The Other Side of the Gate: Reputation, Power, and Post-Market Regulation -- CHAPTER TEN The Détente of Firm and Regulator -- CHAPTER ELEVEN American Pharmaceutical Regulation in International Context: Audiences, Comparisons, and Dependencies -- CHAPTER TWELVE Conclusion: A Reputation in Relief -- PRIMARY SOURCES AND ARCHIVAL COLLECTIONS -- INDEX -- Illustrations -- 2.1. Change in Probability of Pro- Regulatory Vote for Every Additional UMMA Firm Headquartered in Senator's State -- 2.2. An Elixir Sulfanilamide Label, 1937 -- 2.3. Distribution of Massengill's Elixir Sulfanilamide (USDA Report to Congress, 1937) -- 2.4. The Joan Nidiffer Photo, in Report of the Secretary of Agriculture, 1937.

3.1. Edwin Goldenthal's Halting of the NDA for Trancopal, April 1958 -- 3.2. The Published New Drug Application Form of 1956 -- 3.3. FDA Food versus Drug Enforcement, 1947-1954 -- 3.4. Quantiles of the Approval Time Distribution for New Molecular Entities, 1950-1964 (by year of submission) -- 3.5. FDA Approval Hazard Ratios for NMEs under Three Successive Regimes, 1950-1968 -- 4.1. Thalidomide Images from the National Enquirer -- 4.2. The Washington Post Thalidomide Story of July 15, 1962 -- 4.3. Major Newspaper Articles Mentioning "Thalidomide" -- 4.4. Kennedy Awards the Distinguished Civilian Service Medal to Frances O. Kelsey, 1962 -- 5.1. Number of Major Newspaper Articles Mentioning "Thalidomide" and Number Mentioning FDA and "Protect," 1960-1985 -- 6.1. NCI- FDA Memorandum of Understanding (January 1979) -- 7.1. Bureau of Drugs Organizational Chart -- 7.2. Percentage of NME Applications "Rejected" or Withdrawn, 1976-1998 -- 7.3. Relative Speed of Approval by Therapeutic Category, Approved NMEs Submitted 1962-1985 -- 7.4. Expected Duration of Approval by Therapeutic Category, NMEs Submitted 1986-2004 -- 7.5. Change in NME Review Time (months) for Every Standardized Increase in Media Coverage of NME's Primary Indication Disease, 1976-1998 -- 7.6. Change in Probability of Pre- Market Advisory Committee Consultation for Every Standardized Increase in Media Coverage of NME's Primary Indication Disease, 1992-2004 -- 7.7. Average Approval Times by Order of Entry, 1962-2000 -- 7.8. Paragraphs from William Gyarfas' October 24, 1978 Recommendation for Approval of Cisplatin (Platinol) for Testicular and Ovarian Cancer -- 7.9. Percentage of NME Approvals in December, 1970-2000 -- 8.1. Additional Drug Projects Abandoned for Every Standardized Shock in Sponsor Firms' Asset Price Induced by FDA Rejection or Delay.

9.1. Change in Probability of Black- Box Label Warning when Average Tenure of Approving Division Moves from Minimum to Mean -- 10.1. Change in Probability of Non- Approvable Letter Associated with One- Standard- Deviation Increase in Sponsor's Previous INDs -- 10.2. Average NMEs Approval Time by Sponsor's Previous NMEs -- Tables -- I.1. Features of U.S. Pharmaceutical Regulation Adopted in Other Nations -- 2.1. Subject Headings in the USDA's Report on Elixir Sulfanilamide (November 1937) -- 2.2. Comparison of S.5 before and after Sulfanilamide Tragedy and Wallace Proposal -- 3.1. Selected Members of the Post-War Cohort at the U.S. Food and Drug Administration, 1947-1963 -- 3.2. Variants of Coal-Tar Dyes Permitted in Marketing, by Country, 1954 -- 4.1. Partial Summary of Changes Effected by Kefauver-Harris Amendments of 1962 -- 4.2. References to Phased Clinical Studies in Western Medical Literature, 1950-1980 -- 5.1. Membership of the HEW Advisory Committee on the FDA, September 1960 -- 5.2. Membership of the Advisory Committee on Investigational Drugs, January 1965 -- 5.3. Membership of the Medical Advisory Board (FDA Bureau of Medicine), 1969 -- 5.4. Committee Memberships Formally Managed by the FDA, 1967 -- 5.5. FDA Public Advisory Committees, 1967 -- 5.6. List of Congressional Hearings on Pharmaceutical Regulation at FDA, 1960-1980 -- 5.7. Frequency of Agency Mentions in Major Newspaper Articles, 1960-2007 -- 7.1. Medical Officers in the Investigational Drug Branch, Bureau of Medicine, U.S. Food and Drug Administration, 1964 -- 7.2. Ten Possible Outcomes in Treatment -- 7.3. Disease-Specific Entry-Order Gradients, Expressed as Elasticities -- 9.1. Searle's Experience with New Drug Approval before and after the 1968 Report -- 9.2. Drug Changes Requiring a Supplemental NDA, 1970-2006.

9.3. Required Label Sections from Uniform Labeling Requirements from 1979 -- 10.1. Smith Kline and French Corporate Leadership after 1971 -- 10.2. Approval Probabilities (Expressed in Percentages), by Quantiles of Firm Sales Distribution NMEs Reviewed, 1977-2000 -- 10.3. Rank Ordering of Aggregate Advantage for Firms Sponsoring More than 1 Percent of Approved NMEs, 1977-2000 -- 10.4. Variables Associated with Probability of Receiving a Priority Rating, NMEs Submitted 1977-2000 -- 11.1. Cross-National Dependencies in Global Pharmaceutical Regulation in the Twentieth Century -- 12.1. "Rating the FDA".